FDA re­veals sec­ond wave of tainted drugs

19 man­u­fac­tur­ers, 23 prod­ucts im­pli­cated in widen­ing scan­dal

The China Post - - FRONT PAGE -

Tai­wan’s Food and Drug Ad­min­is­tra­tion ( FDA,

) is­sued a sec­ond wave of prod­uct warn­ings and re­calls yes­ter­day, as the re­cent spate of tainted drugs con­tin­ues to rock the is­land. The FDA’s list of drugs con­tain­ing industrial-grade mag­ne­sium car­bon­ate now in­cludes a to­tal of 19 man­u­fac­tur­ers and 23 over-the-counter prod­ucts. (A link to the FDA’s list can be found at the end of this ar­ti­cle.)

The list of tainted prod­ucts in­cludes well-known brands in the area of stom­ach and in­testi­nal medicine, such as Hsin Wan Jen’s Jin Shi Jia brand ( ,

), U.C. Pharma’s Teh Wei brand ( ,

) and Tai­wan Tan­abe Pharma’s Wei Bao Ding brand (

, ). Ac­cord­ing to the FDA, the listed drugs must be re­moved from store shelves by April 22. Fur­ther­more, vi­o­lat­ing drug man­u­fac­tur­ers’ must com­plete a to­tal prod­uct re­call within 30 days, with the FDA is­su­ing an or­der to seal the com­pa­nies’ in­ven­to­ries and sus­pend their ship­ments. Un­der the Phar­ma­ceu­ti­cal Af­fairs Act ( ), the com­pa­nies face fines of be­tween NT$60,000 (US$1,920) and NT$300,000, the FDA said.

The FDA con­ducted fur­ther in­ves­ti­ga­tions from April 13 to April 17, tar­get­ing a to­tal of 48 dif­fer­ent com­pa­nies, of which 19 were found to in­clude mag­ne­sium car­bon­ate that had not been preap­proved.

Yung­shin Pharm (

), Ming Ta Chem­istry Pharma ( ) and Hsin Lin Hsin

) their Sheng ( have proac­tively re­moved prod­ucts from stores.

In a state­ment posted on its of­fi­cial web­site Hsin Wan Jen Chem­i­cal and Phar­ma­ceu­ti­cal claimed that its prod­uct con­tained Ja­pan-sourced “Shi­raishi Cal­cium” which is con­sumer­grade mag­ne­sium car­bon­ate. The com­pany de­fended its prod­uct as ad­her­ing to Ja­panese phar­ma­ceu­ti­cal stan­dards and safe for con­sump­tion.

Last week a sim­i­lar in­spec­tion of 27 firms found that 13 could not prove the cer­ti­fied us­age of their mag­ne­sium car­bon­ate or cal­cium car­bon­ate that were used in a to­tal of 23 prod­ucts.

The full list of stom­ach and in­testi­nal drugs tested to con­tain industrial- grade mag­ne­sium car­bon­ate can be ob­tained here: http:// bit. ly/ 1CXKjKN ( hy­per­link ab­bre­vi­ated from FDA’s of­fi­cial por­tal).

CNA

Stores of tainted stom­ach and in­testi­nal drugs are gath­ered and sealed by the Taoyuan Depart­ment of Public Health, yes­ter­day. Fol­low­ing an in­ves­ti­ga­tion by the Food and Drug Ad­min­is­tra­tion, drugs found with unau­tho­rized amounts of industrial-grade mag­ne­sium car­bon­ate are re­quired to be taken off shelves by late af­ter­noon, April 22.

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